Category Archives: Localization

Translating your content into multiple languages can help you expand your business to global markets and increase your brand prominence abroad. Quality is key to your global success, therefore you should make sure the translations you get are accurate, error-free and clearly understood by your target audience.

Although there is no specific formula you can use to measure quality, especially in a language that you don’t speak, there are several ways to ensure a positive outcome before, during and after the translation process. Use this checklist of quick tips and you’ll be able to effectively speak to your customers in their native language.

Be willing to invest in translation: If you think translation quality is not important, then think again! Low-quality translations may not only damage your company’s reputation but may also cost you a lot of time and money. If you want to get high-quality, professional translation, you need to have a budget for it.

Choose your translation provider wisely: With so many translation agencies out there, it’s hard to know which one you should trust. But if you do your homework, you can find some useful information that will help you pick the right translation provider for your organization. Make sure this provider has expertise in your industry by checking their current clients.

Plan ahead: Once you decide to have your content translated, you should contact your translation provider as soon as possible. Remember, a good translation takes time – it may take the same time as creating the content. If you expect large volumes or short turnaround times, you should inform your translation provider in advance, so they can plan their resources accordingly.

Prepare your content for translation: A great translation starts with a great source text. You cannot expect the translation to improve upon the poor quality of the original. Ask from your copywriters to be concise and clear, and to double-check the content they create for grammar, spelling and punctuation errors. When it comes to software strings, try to include comments and/or screenshots, so as to provide the translators with as much context as possible. This will help you prevent back-and-forth communications and speed up the translation process.

Collaborate closely with your translation provider: Translation is a difficult process. Providing precise instructions, reference material, glossaries and style guides, not only could make this process easier, but it could also ensure high-quality results from the start. In case of queries or clarifications, try to answer to all questions promptly and clearly and, what is most important, listen carefully to your translators’ concerns and be open to their suggestions.

Use third-party evaluation services: A great way to assess the quality of your translated content is to have a third-party provider review it. Third-party reviews add value to your content if they are performed by experienced, in-country linguists who have a good understanding of the local market and your brand, are not focused on mere error detection, and approach the initial translation in a collaborative and not competitive way.

Ask your audience: The best way to evaluate the quality of your translated content is to ask feedback from your users. Consider adding a feedback/rating feature to find out whether your content is clearly understood. This way you will get useful information about the quality of your translations directly from your customers, and you will be able to improve your content.

First of all, you need to embrace the fact that this risk is real. Be proactive at the early stages of project planning and try to accurately interpret project requirements. Adopt a risk management methodology and try to spot any future problems, needs and setbacks. Whether that is poor scope stability, time consuming processes or insufficient project prep time, you need to identify and eliminate all major shortcomings. Setting clear goals from the start will help you avoid extra work and possible delays.

Lakein’s Law: Failing to plan is planning to fail

Quite often, when project managers receive tight-turnaround projects they rush into execution without doing the proper preparation and planning first. But it is exactly in those cases when we lack time to plan, that we should take the time to plan. Very often, at the early stages of a project, when no one is doing actual project work, rather they are engaged in project preparation, analysis and planning, this is often wrongly interpreted as doing nothing. Yet when it comes to project planning, you should take the time you need. Do not give the go-ahead unless you are certain that you have gathered all the necessary information and covered all aspects of the project.

Parkinson’s Law: Work expands to fill the time available

You have a week to finish a proposal, and yet you wait until Friday afternoon to finalize it. You have two months to work on a localization project and you make the last QA checks 2 hours before delivery. Do those scenarios ring a bell?

Another example of Parkinson’s Law is cases when you have a whole week to complete a 2-hour task. When you have all this time on your hands, there is a good chance that this task will creep up in complexity and become more intimidating so as to fill a whole week. It doesn’t necessarily mean that it’s extra work that will fill up all the extra time, it might just be the stress and tension about having to get it done. These situations can be nerve-racking and mentally challenging. To avoid them, set clear deadlines for all project stages, from vendor hand-off to QA, DTP, LSO and final delivery to client. Impose strict but reasonable time constraints for every project step and make the whole team stick to them.

Cohn’s Law: The more time you spend in reporting on what you are doing, the less time you have to do anything

Avoid long, unproductive discussions and meetings. A successful meeting should be all about sharing ideas, asking the right questions and finding the right answers and should only be held if it adds value to the project. Pick the right team members to attend the meeting, assign responsibilities, focus on solutions and end the meeting with action items.

The same goes for written reports. Avoid long, extremely detailed reports. Nobody has the time (or actually wants) to read a 10-page report on the progress of a project. Make sure it’s accurate and contains all the right information but keep it short and simple!

Constantine’s Law: A fool with a tool is still a fool

Software tools are meant to make our work (and life) easier. But with the vast range of translation management programs, CRM software and CAT tools that are offered in the translation market, sometimes we get so overwhelmed that our work ends up being more complicated than it should. Primarily, try to leverage the software you already have at your disposal and make sure you are using all the features it has to offer. If you are experimenting with new tools, do your homework first, then choose the ones that fit your business and make sure you get a proper and thorough training.

Kinser’s Law: About the time you finish doing something, you know enough to start

Do a post-mortem after every major project or in defined intervals for ongoing projects. Sometimes that would be a simple “What have we learnt doing this?” and other times it will be a complete report on time, cost and performance.

Part of it is also measuring the success of your project. A project constitutes as successful if it results in profit, if it brings new knowledge to the organization, if it helps the business expand to new markets or if it improves the existing processes.

Also, try to have your post-mortem directly after a project concludes, while the details are still fresh in your mind. After a while, we tend to forget the things that went wrong in a well-executed project and vice versa. If a project doesn’t go that well, we lose sight of successes as we try to figure out what the problems were.

*This article was part of the 1st edition of “The Elia Handbook for Smart PMs” published by the European Language Industry Association

There is no doubt that Machine Translation (MT) is nowadays one of the major trends in the translation and localization ecosystem. Everyone is talking and debating about it in social media, blogs, newspapers and at conferences and almost everyone, including businesses, government bodies, translation agencies, technologists and even freelance translators, is trying their hand at it. If your business or translation agency is also considering getting on the MT bandwagon, you might find the following tips useful:

Remember that MT is an investment and should form an integral part of your localization and overall business strategy. That is, unless you have your own IT/NLP (Natural Language Processing) department or are big enough to set up such a department, you’ll have to turn to the pros, in this case MT providers. With their experience, they‘ll help you determine what your needs are and how best to fulfill them in terms of system (rules-based, statistical, neural, hybrid), languages, types of texts, confidentiality, availability (onsite or in the cloud) and pricing, among other things.

Make your market research as thorough as possible. You might be surprised, but as you’ll find out the market is rather huge with lots of alternatives on offer. Ask around and more importantly, ask from each MT provider you contact to provide you with a list of criteria they consider the most important in choosing an MT solution. This way, you’ll be able to collate the information you gather into a single list of criteria that are important to you and make an informed decision based on your own needs, capabilities and aspirations.

Set realistic expectations. No MT system will work out of the box, no matter the amount of initial training it receives. You’ll have to invest time and money in order to reap the benefits of MT. In addition, be realistic regarding the adoption of post-editing by your freelance translators and beware of losing your most valued partners. Putting aside the gross generalisation that translators dislike MT and technology in general, many translators are indeed reluctant to take on post-editing tasks for a variety of reasons, the most important of which is the fact that because of the way they are currently practiced by some in the translation industry, MT and post-editing are often viewed as tools mainly targeted at lowering translation rates.

Bring in the translators and/or agencies you work with from the outset, even before committing to MT and a particular system. Their collaboration and input might make all the difference to the success or failure of your MT venture. Bear in mind that although the role usually reserved for translators as far as MT is concerned is that of the post-editor, translators can also be of immense help in other related areas, such as MT evaluation and the maintenance and clean-up of translation memories (TMs) used in the training of MT engines.

Hopefully, these tips will help you in your first exploratory steps with MT. But remember, adopting MT is by no means obligatory and you’ll be able to review your circumstances and decision further down the road. And whether you decide to go down the rabbit hole or not, rest assured that your trusted Commit linguists are here to help you deliver your products and services, as well as market your brand in the local language, and who knows, accompany you on your MT journey.

This is a very good question for businesses wanting to expand their activities beyond their boundaries and go global. Even though English is a commonly used language in many markets, talking to people in a language they understand in depth seems to achieve much better results.

If we take a step back and consider the role of global marketing or the reasons why businesses want to expand in foreign markets, we will start to see the usefulness of the content adaptation to the language the audience understands best. Businesses want to become global for two basic reasons: increase their sales and boost their brand’s reach. The fastest road to increase sales is awareness – through an effectively localized marketing content, that will be global and local at the same time. Global because it will still convey the same consistent message of a business throughout the world and local because it will be customized in a way to reflect the experiences, the values and the culture of prospective local clients. The fundamental purpose of marketing is to penetrate the target audience and get closer to people. This can be achieved only through the language the audience understands best, as this language will become the means to draw their attention, make them want to learn more, and finally persuade them that the promoted product or service is what they really need.

Even if people tend to use English terminology in some industries, the whole communication still needs to be in the audience’s native language as this is the only way the message can resonate with them and touch their heart and mind – leading them to the decision-making process. The language that people understand is the one they will use to search content, read articles, or view a quick video ad from their devices during their free time – it is also the language in which they will share the information with their friends. It is more than obvious that this is the way for businesses to create a personal connection with consumers. The traditional patterns of the one-size marketing campaigns seem to progressively give way to more personalized and interactive approaches. Going even further, localization in marketing material can be the key for differentiation.

That said, we can easily assume that what we need here is not just translation but localization in its full meaning – adaptation, customization and creativity, taking into account differentiation. This is the field where localization can be really fruitful. Modern tools open the way to localization for videos, interactive content and anything that could create a one-to-multiple, but also personal relationship with people, anywhere in the world. Studies have shown that marketing globalization can bring a drastically improved return on marketing expenses.

At this point, it would worth mentioning the role of Machine Translation. It has become one of the main trends in the localization world and we cannot ignore the advantages it can bring in terms of costs and time efficiency. However, its use in marketing content has been greatly debated. If we consider, as mentioned above, that translation in the traditional meaning of the term would not be remotely enough, we can easily assume that marketing material wouldn’t be the ideal candidate for Machine Translation, where the different nuances of a language are usually left out of the whole process. And, most importantly, we would lose authenticity. Marketing localization is a process that can be developed exclusively between humans. The original message should be felt and conveyed to evoke the same feelings to other people. There is no machine that can feel and adapt content and create feelings from one culture to another. This is also a way for businesses to show that they really care for their audiences…

The pressure for price reductions holds strong throughout markets and industries, both for products and services, for many years now and will continue to do so for many years to come. However, according to the law of supply and demand, a low supply and a high demand increases price, while the greater the supply and the lower the demand, the lower the price tends to fall.

For parties in the translation industry, it is common knowledge and a topic visited often in conferences that reliable, experienced and qualified translators and editors are not that many – no matter the language pair – and even if someone argues that they are, then usually it is their availability that is limited or they are lacking in specialization – always compared to the demand!

So, the first half of the law should apply here, right? The answer is “no”! Despite the very optimistic predictions for the growth of the industry, compared to the stability or even slump in other industries due to the recent financial crisis, the pressure for price reductions in the translation and localization industry is more than ever. Why is that? Maybe because translation is considered as an afterthought in the development of any given product, and often of so little visibility that it gets a tiny bit of the allocated budget, if any? Maybe because we, as professionals in the field, have not fought enough to elevate our ‘product’ to the place it should be in our buyers’ minds? Maybe because technology has taken its toll? Maybe because non-professionals have entered the profession offering ridiculously low rates for a respectively low-quality ‘product’? You can pick and choose, but I would not want to get into that.

Instead, let’s take this for granted and see how we can respond to that fact in a way that is respectful of our customers, our businesses and our resources, and still lead a viable business.

Let’s start by trying to understand our customers’ needs and educate them on our workflow and its importance for their end ‘product’.

There are certain steps a text must go through before a high-quality translation can be delivered. Of course, there is a reason for that and it’s not out of a whim that localization agencies favor the translation & editing process, nor because we want to add to our customers’ spend. Language is flexible. Language is subjective. Language is preferential. Language is also fixed and objective (i.e. industry terminology). Humans create language and they choose how to do it, and each individual may choose a different way, a different word, a different meaning… and all may be saying the same thing! So, yes, humans need to be involved in your translation projects, and the more they are involved, the better it is for you and your content, because the more chances there are that their translation gets closer to YOUR way, to YOUR word, to YOUR meaning. How much time, effort and energy have you put in and how many different people have you involved in the creation of your content, or even your ’slogan’? If you think about it, from enough to too much. So, if it was so challenging to settle on a phrase or to finalize your initial content, how can its translation be considered an easy task, especially when it involves many different markets and cultures?

Our advice would be that you should not try to save from compromising processes and eliminating steps (which correspond to people). Instead you should try to locate what you really need to translate and into which languages, evaluate and streamline your translation processes. If this is something new to you or you don’t know how to go about it, ask us; we can help.

And some more seasoned translation & localization services buyers might question the role of humans and ask where technology is in all that. Although, technology was late to enter our industry and help us benefit, there are quite a few tools that can facilitate our work, and the savings time-wise have been translated to real savings for the customers. Customers must always make sure that their language service provider reflects those savings from CAT tools in their invoice offering discounted rates for previously translated (fully or partially) content. Another new trend is machine translation (MT). It is undeniably a considerable advancement in our industry and will most probably play a huge role in how the future of localization will be shaped, but it does not have a universal application. It can serve as a first draft in some types of fixed-language texts, like manuals, to increase the speed and the performance of human translators, and free machine translation engines can be used to give you the gist of a text for your personal understanding; but, raw MT output is not ‘publishable’ text — at least not yet and not where the message matters. Ιt is merely usable in only some language pairs and in no case does it serve the broad spectrum of the languages of the world, it cannot cater for more creative content, and don’t think of only sophisticated marketing content, just try to machine translate your Facebook status update and see what the engine comes up with in various languages.

In every case, we need to invest in and make the most of all available tools and technologies, not only to save money for our customers but to also streamline and standardize our processes, facilitate our project managers and our linguists, monitor and report on our workflows, and lead a transparent and healthy business.

In terms of business practices, price reductions are usually pushed down to the lower levels of the supply chain, which can either be us as agencies or our external resources. In both cases though, this level involves the actual people who do the actual work, and these are indeed those of value to the customer. In the same way agencies recruit for expertise and knowledge, and train their in-house staff to new trends, tools and methodologies to optimize efficiency, the same investment should be considered for external collaborators. Individuals have invested both time and money to specialize and should be able to keep doing so if they are to continue to efficiently support us and, of course, our customers. Hence, although, regular flows and high volumes or long-term projects can of course justify a negotiation to a certain extent, crunching fees should not be adopted as a standard practice, as it is important that all parties involved in this transaction, be it the customer, the intermediary(ies) or the resources, feel that this is a mutually beneficial relationship.

Ultimately, I feel that the way we conduct our business will determine the quality of customers we attract; fair and reasonable practices will most probably attract fair and reasonable customers, and talent will gravitate towards places it can grow.

When companies seeking to expand to foreign markets decide to use translation as an enabler of greater brand awareness and more sales, there is one thing that they should not overlook: What is their source content’s quality? And is it global-ready?

“Translation errors” are often a result of poorly written or unclear source text. How often don’t translators puzzle over the intended meaning of a sentence, on how to deal with inconsistent use of terminology, incorrect grammar structures, ambiguities, non-uniform style and other source related issues?

Often there is not the opportunity to obtain clarifications, and translators have to make an educated guess about the intended meaning or the desired approach relying on their research skills, professional experience and best judgment. And this could sometimes mean an incorrect translation or a target text that does not measure up.

When localization planning and timeframes allow for it, there can be multiple waves of questions and answers, with query resolution not always guaranteed. Especially for large scale projects, this can have a significant impact on cost, workflow, deadlines and product release.

Quality technical writing is a key factor in avoiding such situations. When creating your global market targeted material to be translated into several languages, there are some things you need to consider in order to ensure high translation quality, lower cost and faster speed.

After identifying your audience, defining your purpose, obtaining an in-depth knowledge of the material and organizing your thoughts, planning must focus on setting and using naming conventions for a consistent output. You can document these conventions, along with processes and terminology in the form of style guides and glossaries.

When it comes to the writing task itself, here is what you should keep in mind:

Time should be allowed for drafting, reviewing and editing.

The content should be translation friendly, meaning that the translator can get it right to the point. Clarity, brevity, simplicity and correct word choice for example, contribute to this point.

Prefer active voice for straight forward communication.

Define what may not be familiar (such as abbreviations, acronyms).

Avoid the use of jargon and idioms.

Make efficient use of words (eliminate redundancy, remove needless words).

Use consistent phrasing to say the same thing multiple times.

All these tips will make your content easier to translate, will speed-up the translation process and reduce editing rounds. Moreover, your original document will be accurate, precise and tightly-written, optimized for the domestic audience.

Moving on to the actual localization process and selecting the right partner is the next challenge. Choose wisely and trust your content to an experienced language services provider. They will use native, certified translators whose expertise matches your type of content, experienced project managers and industry-leading localization tools ensuring consistency, confidentiality and a high-quality output.

Refugee crisis, terrorist attacks, so many unfortunate crisis situations seem to have happened last year that affected everyone in our globalized world: civilians, governments, businesses. However, how often do we think of the importance of communication in times of crisis?

Are you considering taking your first steps in the global market, in an attempt to reach international audiences with your products or services? With the use of social media and the Internet, the world has become a much smaller place. Our society is globally connected and many people around the world can now access your products or services. But going global is no easy task! It requires time, effort and money. Read our 10 tips and make sure you’re on the right track.

As mHealth apps are changing the standards of healthcare services and open up new possibilities for patients and doctors alike through a constant evolution of innovative technologies and brilliant ideas, the regulatory standards and localization processes are called to take a step further and grow in tandem, putting the spotlight on the safety and accessibility of mHealth app users. In this post, we take a look at all the special regulatory terms and conditions that apply to the localization of mHealth apps.

An important advantage of the “connected world”, apart from the unlimited access to all kinds of information, is that it brought together previously “disconnected” people, groups or crowds – giving them the opportunity to become more active and engaged in the world around them. Read this post and learn more about the advantages and disadvantages of this method.

An important advantage of the “connected world”, apart from the unlimited access to all kinds of information, is that it brought together previously “disconnected” people, groups or crowds – giving them the opportunity to become more active and engaged in the world around them.

The concept of “crowdsourcing”, meaning the involvement of non-specialists to tasks that were traditionally held by professionals, found a more fertile environment to evolve. Localization could not be an exception, being an already open-minded field by nature. The continuously increasing needs for localization make us want to sit back and reconsider the pros and cons of crowdsourcing. Let’s see some basic points:

What is considered as the main and obvious benefit of crowdsourcing is cost saving. People are much less compensated than professionals – or work for free.

Moreover, there is no doubt that crowdsourcing ensures more availability – it is much easier for a big community of people to achieve super-fast turnarounds than a restricted group of professionals working on a specific project.

Thanks to crowdsourcing, more languages are saved from oblivion because when it comes to minority languages it is not always possible to find professional support. The input of the crowd is extremely valuable at this case.

On the other hand, the value of professional services is undeniable. Not because a community of volunteers cannot provide good translations, but because of the possible lack of expertise and skills. If we think that even experienced linguists are not always qualified for all kinds of projects, we can easily imagine that it is even more difficult to find specialized people in a free community. And then the basic purpose of localization can be lost: we want to speak the language of our audience in order to approach them in a more direct way. But this cannot be achieved without high quality translations.

Going further, why should we expect from non-specialists who work for free to provide high quality translations and be responsible for the accuracy of their work? We would therefore need a specialized pool of reviewers in order to ensure the quality of the final translations. And we should always take consistency into account, which is one of the most important aspects of the content we provide. But how easy is it to keep consistency among people in a free community?

Another basic characteristic of crowdsourcing, is that it should be open to everybody, by definition. How easy would it be to handle the risks that this open model can incur?

It is obvious that a strong professional support is necessary for the coordination of crowdsourcing. Should we still think of crowdsourcing as a much cheaper solution for our localization needs?

All that being said, one would think that crowdsourcing has mainly disadvantages. This is not true. Because we haven’t still mentioned the most valuable benefit of crowdsourcing: the input of people. The feedback of our clients or the users of our products. In short, the “wisdom of the crowd”. This is the opportunity we have to listen to our audience and an alternative way to get their feedback. The more input we have (and this is a matter of statistics!), the more likely we are to end up with the best suggestion.

Summarizing the pros and cons of crowdsourcing, we could say that it can be a very fruitful process if put in place based on some standards. The ideal way to use it is in parallel with professional support and as a separate process. But we should be sure that we are able to mitigate the cons in order to benefit from the pros…

It’s been a week after the ELIA ND event in Brussels but it’s never too late for an impressions review, right?

This year, Elia’s Networking Days event was held in the heart of the city of Brussels, very close to the astonishing Grand Place and the Galeries Royales Saint-Hubert. Commit was represented by General Manager and former ELIA Director Spyros Konidaris, Operations Manager Vasso Pouli and Account Manager Nikoletta Kaponi.

The mix of people, sessions, topics, venue and location made this edition of Networking Days another successful event. Here are some highlights of the conference through our eyes:

The workshop From Manager to Leader – develop your leadership skills by Eszter and Tamás Avar gave us some very useful insight into what leadership consists of and how it is different from managing, and they did this by allowing us to experiment hands-on with the abilities and potential of human behavior. The workshop was a window to a new school of thought and we hope we get the chance to see more of that in the future.

On a different note, Inger Larsen shared some of her valuable experience in recruitment and explained why we should value the ‘trouble-maker’ and the ‘finisher’, as she very aptly put it there is usually an angle these people see that others may not.

Analisa Delvecchio’s presentation on the successful adoption of a Translation Management System was literally breathtaking, as she moved from one slide to the next without taking a breath. It was one of the most comprehensive and composed, though more time for Q&A may have been a good idea.

The Customer Analytics session by Madhuri Hegde was rather intriguing, as most attendees could identify with the inflow of unexploited data and Madhuri’s modest tips on how to use this huge pool of customer information to grow our business have definitely hit the spot.

We also got the chance to learn more on the intricacies of crowdsourcing during Yota Georgakopoulou’s session on Microtask translation workflows, which included some very interesting findings from Yota’s work with “external and internal crowds” for the purpose of developing high-quality machine translations for all text types included in MOOCs (Massive Open Online Courses).

On the QA front, Alan Melby presented the Multidimensional Quality Metrics (MQM) framework for developing metrics appropriate for various types of translations, and he also put forward a very interesting definition for translation quality, stating that “Translation quality is: meeting good specs”.

And of course– we were in the heart of Europe after all – the EU track was full of comprehensive information about how to get into the European (and international) institutions’ translation market, and what is expected after we are awarded a contract, with detailed and practical sessions by Claudio Chiavetta and Jean-Paul Dispaux, long-time experts in this field. Additionally, Aikaterini Sylla highlighted how the EU is finally taxonomizing our industry professions.

With our eyes set to the future, we attended the panel discussion on globalization to find out What the future of the future looks like. The panel consisted of globalization-involved professionals from some of the most exciting companies in the world: Netflix, Prezi, The Nielsen Company and ANZU Global. Their insights on the client needs which constantly evolve, diversify and multiply, as well as their different workflows and approaches to localization gave us the bigger picture of the priorities and strategies that leading companies are putting forward when it comes to going global.

Last but not least, the keynote was indeed an eye-opener to how biased we are by definition as human beings not to mention in our professional and business exchanges. It is amazing what a fly in the men’s toilet bowl can do, besides entertain them also reduce cleaning costs, and it is fascinating how we can ‘play’ with human psychology to achieve our goals. “I suppose it is tempting, if the only tool you have is a hammer, to treat everything as if it were a nail.” (Abraham H. Maslow), so here’s to thinking outside the box and to more incisive decision-making!

Training, learning and networking, amidst chocolate, beers and (a lot of) mussels – we wonder what’s in store for the next edition of ELIA’s Networking Days next year in Bucharest!

The rapid technological advances and the ever expanding use of mobile devices, from smartphones and tablets to wearables and wireless sensors, have not left the healthcare sector unaffected.

Mobile health (mHealth), which is defined as “medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants (PDAs), and other wireless devices” by the EU Green Paper on mobile health, is expected to reach the equivalent of US$26 billion at a global level by 2017. With over 100,000 mHealth software apps currently available on the market, and their constantly growing popularity in developed and developing countries around the globe, mobile technology is changing the rules in the way healthcare professionals and patients interact.

The range of mHealth apps is broad and under constant expansion, including useful and valuable tools for both the individuals/patients and the medical staff: apps for vital sign measurement (e.g. blood pressure, heart rate, temperature etc.), blood glucose monitoring and diabetes management, photo-based skin lesion tracking or diagnosis, sensor-based medication compliance monitoring, diary-based pain management. These are just a few examples of how mobile device technology is contributing to the enhancement of healthcare services, allowing for a more evidence-based and patient-centric approach to healthcare, both of which have become more possible than ever via the use of mobile health apps.

While the possibilities for innovative healthcare apps and better healthcare services are ample, an important question arises regarding the reliability and safety of such apps in relation to their users. In answer to this question, the regulatory frameworks that apply to medical devices come to the foreground, setting down requirements and guidelines for the medical app developers and manufacturers to take into account and comply with.

In the US, the FDA has issued a guidance document for mobile medical applications, which are therein defined as “software applications that can be executed (run) on a mobile platform, or a web-based software application that is tailored to a mobile platform but is executed on a server” and which meet the definition of a “medical device” and are to be used:

– “as an accessory to a regulated medical device”, or

– “to transform a mobile platform into a regulated medical device”.

Within the frame of this guidance, if the intended use of an mHealth app, as stated in the relevant labeling materials, “is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man”, then such an app is to be considered, and regulated, as a medical device.

While not all mHealth apps are medical devices, even for those that are, the FDA presents the option of “enforcement discretion” towards apps that pose a lower risk to their users, and intends to regulate more strictly those apps that could pose a higher risk to their users if they were “to not function as intended”. As part of this regulatory framework, the same classification requirements apply (Class I, Class II, and Class III), as with the “traditional” medical devices, in order to ensure users’ safety and their function as per the manufacturers’/developers’ intentions.

On the other side of the ocean, EU has laid out three directives for medical devices: one on Active Implantable Medical Devices (AIMDD), one on Medical Devices (MDD) and one on In Vitro Diagnostic Medical Devices (IVDMD). These directives are currently all in the process of being revised and are soon to be replaced by two regulations, one for medical devices and another for in vitro diagnostic (IVD) medical devices, following a proposal adopted by the European Commission in September 2012. According to this proposal:

“medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific medical purposes of:

– diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability,

– investigation, replacement or modification of the anatomy or of a physiological process or state,

– control or support of conception,

– disinfection or sterilisation of any of the above-mentioned products, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.”

The European Guidelines on the qualification and classification of stand alone software used in healthcare within the regulatory framework of medical devices (MEDDEV 2.1/6) set out the criteria for “stand alone software” (i.e. software that is not integrated within a medical device) which qualifies as a medical device, therein referred to by means of the term “Software as a Medical Device (SaMD)” and further defined as a “software intended to be used for one or more medical purposes that performs these purposes without being part of a hardware medical device”. Apps that fall under the SaMD definition are required to receive a CE mark, same as with other medical devices, and are also subject to the EU medical device classification (Class I, Class IIa, Class IIb, and Class III), for safety and appropriate development and use to be ensured.

Apart from the need for certain mHealth apps to be regulated as medical devices, the manufacturers of such apps also face the need to make their products accessible to as many people as possible worldwide. With over 2.6 billion smartphone users across the globe, 87% of whom always carry their smartphone with them, the potential of introducing a new product in as many markets as possible is very alluring, but also challenging, given the language and culture diversity of the receiving markets.

Surveys have shown that people primarily prefer to download mobile apps in their own native tongue, i.e. the version localized for their own locale, and this preference should perhaps be re-iterated as a need of paramount importance in the case of mHealth apps, given the nature of their functions and the sensitivity of the data processed. But, apart from user-defined needs, specific localization requirements are also prescribed by the regulatory standards of each country, which determine what must be localized in the country’s official language(s) and what may not. Therefore, the localization step becomes a highly important part of mHealth app launches worldwide, in order to ensure not only an improved end-user experience, but also compliance as far as “apps regulated as medical devices” are concerned.

mHealth app localization specifics include the typical elements of medical translation, which focus upon accuracy, terminology consistency, subject matter expertise and optimal quality assurance processes, and also some more technical tasks. Such tasks are the functional testing of the localized app within the mobile operating system(s) (e.g. iOS, Android, etc.) for which it is designed, followed by the fixing of any identified bugs, and the linguistic review of the localized app, i.e. the review of the translated content within-context in order to ensure the correctness of the translations used and to check for any character corruptions or overflowing/truncated text or misplaced content. These tasks allow for a hands-on validation of the localized apps and aim at eliminating functional and linguistic issues which could reduce the usability of the apps, as well as the clarity and precision of their content.

As mHealth apps are changing the standards of healthcare services and open up new possibilities for patients and doctors alike through a constant evolution of innovative technologies and brilliant ideas, the regulatory standards and localization processes are called to take a step further and grow in tandem, putting the spotlight on the safety and accessibility of mHealth app users.